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A Study to Evaluate the Efficacy and Safety of ORMD-0801 (Oral Insulin) in Patients With Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03467932
Recruitment Status : Completed
First Posted : March 16, 2018
Results First Posted : November 8, 2022
Last Update Posted : November 8, 2022
Sponsor:
Collaborator:
Integrium
Information provided by (Responsible Party):
Oramed, Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition T2DM (Type 2 Diabetes Mellitus)
Interventions Drug: Cohort A: ORMD-0801
Drug: Placebo oral capsule
Drug: Cohort B: ORMD-0801
Enrollment 373
Recruitment Details

Patients were recruited into two primary Cohorts, A and B.

Cohort A:

  1. ORMD-0801 1X daily
  2. ORMD-0801 2X daily
  3. ORMD-0801 3X daily
  4. Matched Placebo

Sub-Cohort A 20 subjects Per FDA, excipient matched placebo; randomized single-blind, TID, same schedule as for Cohort A.

Not part of primary analysis.

Cohort B:

  1. ORMD-0801 8 mg 1X daily
  2. ORMD-0801 8 mg 2X daily
  3. ORMD-0801 16 mg 1X daily
  4. ORMD-0801 16 mg 2X daily
  5. Excipient matched placebo once daily
Pre-assignment Details

After screening, patients underwent a 2-week, single-blind placebo run-in period (Visits 1[baseline] and 2), followed by a 12-week treatment period.

Cohort A:

12-wk treatment period, 2 parts. Part 1, dose escalation interval for 2 weeks (Visits 3 and 4) Part 2, stable dose "maintenance" for 10 weeks (Visits 5-9).

;

Cohort B:

12-wk treatment period, 2 parts. Part 1, stable dosing for 2 weeks (Visits 3 and 4) Part 2, stable dosing for 10 weeks, Visits 5-9).

Arm/Group Title Cohort A: ORMD-0801 Once Daily - QHS Cohort A: ORMD-0801 Twice Daily - BID Cohort A: ORMD-0801 Three Times Daily - TID Cohort A: Matched Placebo Oral Capsule Cohort A (Sub-Cohort A): Excipient-Matched Placebo Three Times Daily-TID Cohort B:ORMD-0801, 8 mg Once Daily - QHS: Cohort B: ORMD-0801 8 mg Twice Daily - BID Cohort B: ORMD-0801 16 mg Once Daily - QHS: Cohort B: ORMD-0801 16 mg Twice Daily - BID Cohort B - Matched Placebo Oral Capsule
Hide Arm/Group Description

Dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes)

Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2.

Part 2:

During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

Dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast.

Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2.

Part 2:

During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

ORMD-0801 three times daily - TID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast and lunch.

Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2.

Part 2:

During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

Placebo matched to one of the three active comparator arms. (either QHS, BID, or TID)

Placebo oral capsule: Placebo provided QHS, BID, TID

Excipient matched placebo in a non-randomized single-blind fashion, TID, dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast and lunch.

Placebo oral capsule: Placebo provided QHS, BID, TID

Per FDA, this sub-Cohort A is an exploratory endpoint, and not part of the primary analysis.

ORMD-0801 8 mg once daily - QHS: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes)

Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1.

Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

ORMD-0801 8 mg twice daily - BID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast.

Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1.

Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

ORMD-0801 16 mg once daily - QHS: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes)

Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1.

Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

ORMD-0801 16 mg twice daily - BID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast.

Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1.

Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

Cohort B - Matched Placebo Oral Capsule: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes)

Placebo oral capsule: Placebo provided QHS, BID, TID

Period Title: Overall Study
Started 69 68 69 66 20 15 17 18 15 16
Completed 62 58 58 56 19 13 15 16 11 14
Not Completed 7 10 11 10 1 2 2 2 4 2
Arm/Group Title Cohort A+Cohort B Combined: Matched Oral Capsule Placebo Cohort A: ORMD-0801 Once Daily - QD Cohort A: ORMD-0801 Twice Daily - BID Cohort A: ORMD-0801 Three Times Daily - TID Cohort B:ORMD-0801, 8 mg Once Daily - QD Cohort B: ORMD-0801 8 mg Twice Daily - BID Cohort B: ORMD-0801 16 mg Once Daily - QD Cohort B: ORMD-0801 16 mg Twice Daily - BID Sub-Cohort A: Excipient Matched Placebo Total
Hide Arm/Group Description

Placebo matched to one of the three active comparator arms. (either QHS, BID, or TID)

Placebo oral capsule: Placebo provided QHS, BID, TID

This combined arm does not include the sub-cohort A, Excipient-Matched Placebo which per FDA is an exploratory endpoint, not part of the primary analysis.

Dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes)

Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2.

Part 2:

During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

Dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast.

Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2.

Part 2:

During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

ORMD-0801 three times daily - TID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast and lunch.

Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2.

Part 2:

During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

ORMD-0801 8 mg once daily - QHS: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes)

Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1.

Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

ORMD-0801 8 mg twice daily - BID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast.

Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1.

Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

ORMD-0801 16 mg once daily - QHS: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes)

Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1.

Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

ORMD-0801 16 mg twice daily - BID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast.

Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1.

Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

Data collected from participants who received excipient-matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis. Total of all reporting groups
Overall Number of Baseline Participants 82 69 68 69 15 17 18 15 20 373
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 82 participants 69 participants 68 participants 69 participants 15 participants 17 participants 18 participants 15 participants 20 participants 373 participants
55.92  (9.914) 56.72  (10.766) 55.68  (10.569) 55.22  (11.663) 53.66  (8.22) 56.87  (9.132) 54.98  (11.229) 54.98  (11.785) 64.08  (9.218) 55.73  (10.544)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 69 participants 68 participants 69 participants 15 participants 17 participants 18 participants 15 participants 20 participants 373 participants
Female
33
  40.2%
27
  39.1%
23
  33.8%
29
  42.0%
5
  33.3%
7
  41.2%
7
  38.9%
4
  26.7%
8
  40.0%
143
  38.3%
Male
49
  59.8%
42
  60.9%
45
  66.2%
40
  58.0%
10
  66.7%
10
  58.8%
11
  61.1%
11
  73.3%
12
  60.0%
230
  61.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 69 participants 68 participants 69 participants 15 participants 17 participants 18 participants 15 participants 20 participants 373 participants
Hispanic or Latino
48
  58.5%
36
  52.2%
37
  54.4%
36
  52.2%
9
  60.0%
8
  47.1%
9
  50.0%
8
  53.3%
0
   0.0%
191
  51.2%
Not Hispanic or Latino
33
  40.2%
32
  46.4%
29
  42.6%
33
  47.8%
6
  40.0%
6
  35.3%
9
  50.0%
6
  40.0%
20
 100.0%
174
  46.6%
Unknown or Not Reported
1
   1.2%
1
   1.4%
2
   2.9%
0
   0.0%
0
   0.0%
3
  17.6%
0
   0.0%
1
   6.7%
0
   0.0%
8
   2.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 69 participants 68 participants 69 participants 15 participants 17 participants 18 participants 15 participants 20 participants 373 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.4%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.3%
Asian
0
   0.0%
0
   0.0%
2
   2.9%
1
   1.4%
0
   0.0%
0
   0.0%
1
   5.6%
2
  13.3%
0
   0.0%
6
   1.6%
Native Hawaiian or Other Pacific Islander
1
   1.2%
1
   1.4%
1
   1.5%
1
   1.4%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4
   1.1%
Black or African American
11
  13.4%
7
  10.1%
8
  11.8%
8
  11.6%
3
  20.0%
4
  23.5%
1
   5.6%
1
   6.7%
3
  15.0%
46
  12.3%
White
69
  84.1%
59
  85.5%
57
  83.8%
58
  84.1%
12
  80.0%
11
  64.7%
16
  88.9%
11
  73.3%
17
  85.0%
310
  83.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   1.2%
2
   2.9%
0
   0.0%
0
   0.0%
0
   0.0%
2
  11.8%
0
   0.0%
1
   6.7%
0
   0.0%
6
   1.6%
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/M^2
Number Analyzed 82 participants 69 participants 68 participants 69 participants 15 participants 17 participants 18 participants 15 participants 20 participants 373 participants
31.137  (4.7750) 31.721  (4.9409) 30.447  (4.7710) 31.191  (4.0045) 31.759  (4.4393) 31.005  (5.0333) 31.881  (6.0514) 30.776  (5.4530) 31.310  (5.5976) 31.171  (4.7203)
HbA1c  
Mean (Standard Deviation)
Unit of measure:  Percent HbA1c
Number Analyzed 82 participants 69 participants 68 participants 69 participants 15 participants 17 participants 18 participants 15 participants 20 participants 373 participants
9.46  (1.434) 8.96  (1.281) 9.36  (1.656) 9.64  (1.578) 9.83  (1.759) 8.46  (1.104) 8.96  (1.420) 9.18  (1.687) 8.93  (0.929) 9.31  (1.512)
Diabetes Medications  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 69 participants 68 participants 69 participants 15 participants 17 participants 18 participants 15 participants 20 participants 373 participants
Metformin Alone
22
  26.8%
20
  29.0%
20
  29.4%
12
  17.4%
6
  40.0%
5
  29.4%
7
  38.9%
5
  33.3%
6
  30.0%
103
  27.6%
Metformin, No Sulfonylureas, but At Least 1 Other Medication
13
  15.9%
10
  14.5%
8
  11.8%
12
  17.4%
1
   6.7%
0
   0.0%
1
   5.6%
2
  13.3%
1
   5.0%
48
  12.9%
Metformin with Sulfonylureas Only
33
  40.2%
30
  43.5%
26
  38.2%
33
  47.8%
7
  46.7%
7
  41.2%
8
  44.4%
3
  20.0%
4
  20.0%
151
  40.5%
Metformin with Sulfonylureas and Other Medication(s)
10
  12.2%
5
   7.2%
8
  11.8%
6
   8.7%
0
   0.0%
1
   5.9%
1
   5.6%
3
  20.0%
6
  30.0%
40
  10.7%
Not on Metformin, But On 1 Other Medication
4
   4.9%
4
   5.8%
3
   4.4%
4
   5.8%
1
   6.7%
2
  11.8%
0
   0.0%
1
   6.7%
1
   5.0%
20
   5.4%
Not on Metformin, But On At Least 2 Other Medications
0
   0.0%
0
   0.0%
3
   4.4%
2
   2.9%
0
   0.0%
2
  11.8%
1
   5.6%
1
   6.7%
2
  10.0%
11
   2.9%
1.Primary Outcome
Title Change From Baseline of HbA1C (Glycated Hemoglobin)
Hide Description Least Squares Means change in HbA1C from baseline to Week 12 of the treatment period, where HbA1C is reported in units of percent. The change in HbA1c from baseline to Week 12 is expressed as a change in the value of HbA1C.
Time Frame baseline (Run-in period, Week 0, Visit 1) and Week 12 (follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
Data collected from participants who received excipient-matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Arm/Group Title Combined Cohort A +Cohort B: Matched-Placebo Oral Capsule Cohort A: ORMD-0801 Once Daily - QHS Cohort A: ORMD-0801 Twice Daily - BID Cohort A: ORMD-0801 Three Times Daily - TID Cohort B:ORMD-0801, 8 mg Once Daily - QHS: Cohort B: ORMD-0801 8 mg Twice Daily - BID Cohort B: ORMD-0801 16 mg Once Daily - QHS: Cohort B: ORMD-0801 16 mg Twice Daily - BID
Hide Arm/Group Description:

Placebo matched to one of the three active comparator arms. (either QHS, BID, or TID)

Placebo oral capsule: Placebo provided QHS, BID, TID

Data collected from participants who received excipient-matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.

Dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes)

Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2.

Part 2:

During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

Dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast.

Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2.

Part 2:

During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

ORMD-0801 three times daily - TID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast and lunch.

Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2.

Part 2:

During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

ORMD-0801 8 mg once daily - QHS: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes)

Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1.

Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

ORMD-0801 8 mg twice daily - BID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast.

Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1.

Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

ORMD-0801 16 mg once daily - QHS: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes)

Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1.

Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

ORMD-0801 16 mg twice daily - BID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast.

Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1.

Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

Overall Number of Participants Analyzed 53 59 54 52 13 12 13 10
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent HbA1C
-0.13
(-0.86 to 0.59)
-0.60
(-1.37 to 0.16)
-0.59
(-1.32 to 0.14)
-0.51
(-1.27 to 0.25)
-0.95
(-1.87 to -0.03)
-0.95
(-1.84 to -0.07)
0.12
(-0.80 to 1.04)
-0.50
(-1.47 to 0.48)
2.Secondary Outcome
Title Mean Change From Baseline Over Time for HbA1C
Hide Description Mean change from baseline (Run-In, Week 0 Visit 1) to Part 1, Visit 3 for HbA1C (measured in mmols/mol)
Time Frame Baseline (Run-In:Week 0, Visit 1) to Part 1, Visit 3, elapsed time: 3 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Intend-to-Treat; data collected from participants who received excipient-matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Arm/Group Title Combined Cohort A+Cohort B: Matched-Placebo Oral Capsule Cohort A: ORMD-0801 Once Daily - QHS Cohort A: ORMD-0801 Twice Daily - BID Cohort A: ORMD-0801 Three Times Daily - TID Cohort B:ORMD-0801, 8 mg Once Daily - QHS: Cohort B: ORMD-0801 8 mg Twice Daily - BID Cohort B: ORMD-0801 16 mg Once Daily - QHS: Cohort B: ORMD-0801 16 mg Twice Daily - BID
Hide Arm/Group Description:

Placebo matched to one of the three active comparator arms. (either QHS, BID, or TID)

Placebo oral capsule: Placebo provided QHS, BID, TID

Data collected from participants who received excipient-matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.

Dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes)

Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2.

Part 2:

During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

Dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast.

Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2.

Part 2:

During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

ORMD-0801 three times daily - TID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast and lunch.

Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2.

Part 2:

During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

ORMD-0801 8 mg once daily - QHS: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes)

Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1.

Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

ORMD-0801 8 mg twice daily - BID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast.

Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1.

Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

ORMD-0801 16 mg once daily - QHS: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes)

Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1.

Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

ORMD-0801 16 mg twice daily - BID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast.

Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1.

Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

Overall Number of Participants Analyzed 61 62 62 58 14 13 14 14
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mmol/mol
-2.12
(-4.40 to 0.16)
-2.56
(-4.94 to -0.19)
-1.95
(-4.21 to 0.30)
-2.91
(-5.25 to -0.57)
-3.26
(-6.13 to -0.39)
-5.51
(-8.30 to -2.73)
-2.06
(-4.94 to 0.82)
-1.87
(-4.72 to 0.98)
3.Secondary Outcome
Title Change Over Time in Hb1Ac
Hide Description Change of Hb1Ac from Baseline to Week 10, measured in mmol/mol
Time Frame Baseline (week 0, visit 1) to Week 10, part 2
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat; data collected from participants who received excipient-matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
Arm/Group Title Cohort A+Cohort B: Combined Matched Placebo Oral Capsule Cohort A: ORMD-0801 Once Daily - QD Cohort A: ORMD-0801 Twice Daily - BID Cohort A: ORMD-0801 Three Times Daily - TID Cohort B:ORMD-0801, 8 mg Once Daily - QD Cohort B: ORMD-0801 8 mg Twice Daily - BID Cohort B: ORMD-0801 16 mg Once Daily - QD Cohort B: ORMD-0801 16 mg Twice Daily - BID
Hide Arm/Group Description:

Placebo matched to one of the three active comparator arms. (either QHS, BID, or TID)

Placebo oral capsule: Placebo provided QHS, BID, TID

Data collected from participants who received excipient-matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.

Dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes)

Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2.

Part 2:

During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

Dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast.

Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2.

Part 2:

During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

ORMD-0801 three times daily - TID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast and lunch.

Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2.

Part 2:

During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

ORMD-0801 8 mg once daily - QHS: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes)

Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1.

Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

ORMD-0801 8 mg twice daily - BID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast.

Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1.

Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

ORMD-0801 16 mg once daily - QHS: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes)

Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1.

Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

ORMD-0801 16 mg twice daily - BID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast.

Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1.

Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

Overall Number of Participants Analyzed 53 58 54 50 13 12 13 11
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mmol/mol
-1.27
(-8.88 to 6.35)
-5.95
(-14.05 to 2.16)
-4.95
(-12.62 to 2.73)
-6.16
(-14.22 to 1.90)
-10.34
(-20.01 to -0.68)
-10.71
(-20.02 to -1.40)
-0.25
(-9.94 to 9.44)
-4.66
(-14.61 to 5.28)
Time Frame Each subject was followed for a period of 12 weeks
Adverse Event Reporting Description Data collected from participants who received excipient matched placebo was an exploratory efficacy evaluation and therefore excluded from the primary and secondary analysis.
 
Arm/Group Title Combined Cohort A + Cohort B: Matched Placebo Cohort A: ORMD-0801 Once Daily - QD Cohort A: ORMD-0801 Twice Daily - BID Cohort A: ORMD-0801 Three Times Daily - TID Cohort B:ORMD-0801, 8 mg Once Daily - QD Cohort B: ORMD-0801 8 mg Twice Daily - BID Cohort B: ORMD-0801 16 mg Once Daily - QD Cohort B: ORMD-0801 16 mg Twice Daily - BID Excipient Matched Placebo -TID
Hide Arm/Group Description

Placebo matched to one of the three active comparator arms. (either QHS, BID, or TID)

Placebo oral capsule: Placebo provided QHS, BID, TID

Per FDA, the sub-Cohort A, excipient-matched placebo TID is an exploratory arm and is not part of the primary analysis.

Dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes)

Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2.

Part 2:

During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

Dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast.

Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2.

Part 2:

During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

ORMD-0801 three times daily - TID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast and lunch.

Cohort A: ORMD-0801: Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2.

Part 2:

During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

ORMD-0801 8 mg once daily - QHS: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes)

Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1.

Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

ORMD-0801 8 mg twice daily - BID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast.

Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1.

Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

ORMD-0801 16 mg once daily - QHS: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes)

Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1.

Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

ORMD-0801 16 mg twice daily - BID: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes) and 30-45 minutes prior to breakfast.

Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1.

Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.

Exploratory endpoint not part of primary analysis per FDA
All-Cause Mortality
Combined Cohort A + Cohort B: Matched Placebo Cohort A: ORMD-0801 Once Daily - QD Cohort A: ORMD-0801 Twice Daily - BID Cohort A: ORMD-0801 Three Times Daily - TID Cohort B:ORMD-0801, 8 mg Once Daily - QD Cohort B: ORMD-0801 8 mg Twice Daily - BID Cohort B: ORMD-0801 16 mg Once Daily - QD Cohort B: ORMD-0801 16 mg Twice Daily - BID Excipient Matched Placebo -TID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/82 (0.00%)      0/69 (0.00%)      0/68 (0.00%)      0/69 (0.00%)      0/15 (0.00%)      0/17 (0.00%)      0/18 (0.00%)      0/15 (0.00%)      1/20 (5.00%)    
Hide Serious Adverse Events
Combined Cohort A + Cohort B: Matched Placebo Cohort A: ORMD-0801 Once Daily - QD Cohort A: ORMD-0801 Twice Daily - BID Cohort A: ORMD-0801 Three Times Daily - TID Cohort B:ORMD-0801, 8 mg Once Daily - QD Cohort B: ORMD-0801 8 mg Twice Daily - BID Cohort B: ORMD-0801 16 mg Once Daily - QD Cohort B: ORMD-0801 16 mg Twice Daily - BID Excipient Matched Placebo -TID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/82 (0.00%)      5/69 (7.25%)      0/68 (0.00%)      3/69 (4.35%)      0/15 (0.00%)      0/17 (0.00%)      0/18 (0.00%)      1/15 (6.67%)      3/20 (15.00%)    
Cardiac disorders                   
Acute Myocardial Infarction  1  0/82 (0.00%)  0 0/69 (0.00%)  0 0/68 (0.00%)  0 1/69 (1.45%)  1 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
Angina Pectoris  2  0/82 (0.00%)  0 1/69 (1.45%)  1 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 0/20 (0.00%)  0
Atrial Fibrillation  2  0/82 (0.00%)  0 2/69 (2.90%)  2 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 0/20 (0.00%)  0
Coronary Artery Disease  2  0/82 (0.00%)  0 0/69 (0.00%)  0 0/68 (0.00%)  0 1/69 (1.45%)  1 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 0/20 (0.00%)  0
Supraventricular Tachycardia  2  0/82 (0.00%)  0 1/69 (1.45%)  1 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 0/20 (0.00%)  0
Myocardial Infarction  2  0/82 (0.00%)  0 0/69 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
General disorders                   
Chest Pain  2  0/82 (0.00%)  0 0/69 (0.00%)  0 0/68 (0.00%)  0 1/69 (1.45%)  1 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/15 (6.67%)  1 0/20 (0.00%)  0
Death  2  0/82 (0.00%)  0 0/69 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
Infections and infestations                   
Sepsis  2  0/82 (0.00%)  0 0/69 (0.00%)  0 0/68 (0.00%)  0 1/69 (1.45%)  1 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 0/20 (0.00%)  0
Urosepsis  2  0/82 (0.00%)  0 1/69 (1.45%)  1 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 0/20 (0.00%)  0
Osteomyelitis  2  0/82 (0.00%)  0 0/69 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
Pneumonia  2  /82  0/69 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
Renal and urinary disorders                   
Acute Kidney Injury  2  0/82 (0.00%)  0 1/69 (1.45%)  1 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 0/20 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                   
Asthma  2  0/82 (0.00%)  0 1/69 (1.45%)  1 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 0/20 (0.00%)  0
Chronic Obstructive Pulmonary Disease  2  0/82 (0.00%)  0 1/69 (1.45%)  1 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 0/20 (0.00%)  0
1
Term from vocabulary, MedDRA (10.0)
2
Term from vocabulary, MedDRA (21.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Combined Cohort A + Cohort B: Matched Placebo Cohort A: ORMD-0801 Once Daily - QD Cohort A: ORMD-0801 Twice Daily - BID Cohort A: ORMD-0801 Three Times Daily - TID Cohort B:ORMD-0801, 8 mg Once Daily - QD Cohort B: ORMD-0801 8 mg Twice Daily - BID Cohort B: ORMD-0801 16 mg Once Daily - QD Cohort B: ORMD-0801 16 mg Twice Daily - BID Excipient Matched Placebo -TID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/82 (13.41%)      19/69 (27.54%)      6/68 (8.82%)      10/69 (14.49%)      5/15 (33.33%)      2/17 (11.76%)      1/18 (5.56%)      2/15 (13.33%)      13/20 (65.00%)    
Blood and lymphatic system disorders                   
Anemia  1  0/82 (0.00%)  0 3/69 (4.35%)  3 1/68 (1.47%)  1 0/69 (0.00%)  0 0/15 (0.00%)  0 1/17 (5.88%)  1 1/18 (5.56%)  1 0/15 (0.00%)  0 0/20 (0.00%)  0
Cardiac disorders                   
Angina Pectoris  2  0/82 (0.00%)  0 1/69 (1.45%)  1 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 0/20 (0.00%)  0
Atrial Fibrillation  2  0/82 (0.00%)  0 3/69 (4.35%)  3 1/68 (1.47%)  1 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 2/20 (10.00%)  2
Atrioventricular Block First Degree  2  0/82 (0.00%)  0 1/69 (1.45%)  1 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
Palpitations  2  1/82 (1.22%)  1 0/69 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
Supraventricular Tachycardia  2  0/82 (0.00%)  0 1/69 (1.45%)  1 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 0/20 (0.00%)  0
Intracardiac Mass  2  0/82 (0.00%)  0 0/69 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
Myocardial Infarction  2  0/82 (0.00%)  0 0/69 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
Gastrointestinal disorders                   
Abdominal discomfort  2  1/82 (1.22%)  1 0/69 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
Abdominal pain Upper  2  0/82 (0.00%)  0 1/69 (1.45%)  1 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 0/20 (0.00%)  0
Constipation  2  0/82 (0.00%)  0 1/69 (1.45%)  1 0/68 (0.00%)  0 0/69 (0.00%)  0 1/15 (6.67%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 0/20 (0.00%)  0
Diarrhoea  2  3/82 (3.66%)  3 2/69 (2.90%)  2 3/68 (4.41%)  3 8/69 (11.59%)  8 1/15 (6.67%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 3/20 (15.00%)  3
Large Intestine Polyp  2  1/82 (1.22%)  1 0/69 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 0/20 (0.00%)  0
Nausea  2  1/82 (1.22%)  1 2/69 (2.90%)  2 0/68 (0.00%)  0 1/69 (1.45%)  1 1/15 (6.67%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0 1/15 (6.67%)  1 0/20 (0.00%)  0
Pancreatic Cyst  2  0/82 (0.00%)  0 1/69 (1.45%)  1 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 0/20 (0.00%)  0
Cystitis  2  1/82 (1.22%)  1 0/69 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 1/15 (6.67%)  1 1/17 (5.88%)  1 0/18 (0.00%)  0 0/15 (0.00%)  0 0/20 (0.00%)  0
Dispepsia  2  0/82 (0.00%)  0 0/69 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
Immune system disorders                   
Hypersensitivity  2  0/82 (0.00%)  0 0/69 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 1/15 (6.67%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 0/20 (0.00%)  0
Seasonal Allergy  2  1/82 (1.22%)  1 1/69 (1.45%)  1 0/68 (0.00%)  0 1/69 (1.45%)  1 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 0/20 (0.00%)  0
Infections and infestations                   
Acute Sinusitis  2  0/82 (0.00%)  0 1/69 (1.45%)  1 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 0/20 (0.00%)  0
Adenoviral upper respiratory infection  2  1/82 (1.22%)  1 0/69 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 0/20 (0.00%)  0
Body Tinea  2  0/82 (0.00%)  0 1/69 (1.45%)  1 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 0/20 (0.00%)  0
Bronchitis  2  0/82 (0.00%)  0 1/69 (1.45%)  1 1/68 (1.47%)  1 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
Cellulitis  2  1/82 (1.22%)  1 0/69 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 0/20 (0.00%)  0
Conjunctivitis  2  1/82 (1.22%)  1 0/69 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 0/20 (0.00%)  0
Diverticulitis  2  0/82 (0.00%)  0 0/69 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/15 (6.67%)  1 0/20 (0.00%)  0
Gastroenteritis Viral  2  1/82 (1.22%)  1 0/69 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 0/20 (0.00%)  0
Atypical Pneumonia  2  0/82 (0.00%)  0 0/69 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
Osteomyelitis  2  0/82 (0.00%)  0 0/69 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
Nasopharyngitis  2  0/82 (0.00%)  0 0/69 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
Pneumonia  2  0/82 (0.00%)  0 0/69 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
Injury, poisoning and procedural complications                   
Laceration  2  0/82 (0.00%)  0 0/69 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
Metabolism and nutrition disorders                   
Hypokalaemia  2  0/82 (0.00%)  0 0/69 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
Musculoskeletal and connective tissue disorders                   
Back Pain  2  0/82 (0.00%)  0 0/69 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
Mulscle Spasms  2  0/82 (0.00%)  0 0/69 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
Pain in Extremity  2  0/82 (0.00%)  0 0/69 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
Reproductive system and breast disorders                   
Vulvovaginal Discomfort  2  0/82 (0.00%)  0 0/69 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
Skin and subcutaneous tissue disorders                   
Pruritus  2  0/82 (0.00%)  0 0/69 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
Skin Ulcer  2  0/82 (0.00%)  0 0/69 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
Vascular disorders                   
Peripheral Arterial Occlusive Disease  2  0/82 (0.00%)  0 0/69 (0.00%)  0 0/68 (0.00%)  0 0/69 (0.00%)  0 0/15 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/15 (0.00%)  0 1/20 (5.00%)  1
1
Term from vocabulary, MedDRA (10.0)
2
Term from vocabulary, MedDRA (21.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Miriam Kidron, Ph.D.
Organization: Oramed Pharmaceuticals
Phone: +972-2-566-0100
EMail: miriam@oramed.com
Layout table for additonal information
Responsible Party: Oramed, Ltd.
ClinicalTrials.gov Identifier: NCT03467932    
Other Study ID Numbers: ORA-D-015
First Submitted: March 1, 2018
First Posted: March 16, 2018
Results First Submitted: September 19, 2021
Results First Posted: November 8, 2022
Last Update Posted: November 8, 2022